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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 November 2012 |
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Main ID: |
NCT01505621 |
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Date of registration:
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04/01/2012 |
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Primary sponsor: |
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Public title:
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Novel Methodology to Measure Protein Accumulation
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Scientific title:
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Novel Methodology to Measure Protein Accumulation |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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24 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01505621 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Deborah Sheldon |
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Address:
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Telephone:
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507-255-8082 |
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Email:
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sheldon.deborah@mayo.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18-30 years
- Age greater than 65 years
Exclusion Criteria:
- Active or uncontrolled cardiovascular disease
- Chronic kidney disease with serum creatinine = 1.4 mg/dL for women and = 1.5 mg/dL
for men
- Chronic liver disease (elevation in serum transaminases = 3 times the upper limit of
normal)
- Any debilitating chronic illness, including malignancy
- Significant malabsorptive state, including prior gastric bypass surgery or
inflammatory bowel disease
- Diabetes mellitus (types 1 or 2) or glucose = 110 mg/dL.
- Obesity (BMI = 31 kg/m2)
- Anticoagulant therapy (warfarin or heparin) or bleeding disorder that increases risk
of bleeding during a muscle biopsy.
- Anemia (hemoglobin = 11 g/dL)
- Use of medications known to modulate protein synthesis, mitochondrial function,
and/or glucose homeostasis (including ß-blockers and corticosteroids).
- Participation in another study where the 13CPhe was administered during the past 6
months.
- Moderate or high level of structured exercise (on average, = 30 minutes per day and =
2 days per week)
- Pregnancy
- Daily use of tobacco products (smoking or chewing); or smoking =7 cigarettes per
week, on average. Abstinence from tobacco for =3 months is required before
enrollment in the study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aging
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Intervention(s)
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Other: L[ring-13C6]phenylalanine
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Primary Outcome(s)
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Degree of post-translational modifications in plasma and muscle proteins
[Time Frame: 3 weeks]
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Isotopic enrichment of plasma and skeletal muscle proteins achieved by oral ingestion of [13C6]-phenylalanine
[Time Frame: 3 weeks]
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Secondary Outcome(s)
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Assess differences in protein accumulation as a function of age
[Time Frame: 3 weeks]
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Assess differences in protein modification/damage as a function of age
[Time Frame: 3 weeks]
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Secondary ID(s)
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11-004969
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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